Dacomitinib (PF-00299804) As A Single Oral Agent In Selected Patients With Adenocarcinoma Of The Lung

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00818441
First received: January 5, 2009
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

This study will explore the safety and efficacy of the oral PanHER inhibitor PF-00299804 in patients with adenocarcinoma of the lung who are either non-smokers (<100 cigarette, cigar or pipe lifetime) or former light smokers ( less than 10 pack-years and stopped at least 15 years) or have known EGFR activating mutation; or patients with HER 2 amplification or mutation.


Condition Intervention Phase
Carcinoma, Non-small Cell
Drug: Dacomitinib (PF-00299804)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open Label, Trial Of Pf-00299804 In Selected Patients With Advanced Adenocarcinoma Of The Lung

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS);Progression Free Survival rate (PFS) at 4 months [Cohort A] PFS is defined as the interval from enrollment to date of objective progression or death due to any cause. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    The period from study entry until disease progression, death or date of last contact.


Secondary Outcome Measures:
  • Progression-Free Survival (PFS);Progression Free Survival rate (PFS) at 4 months [Cohort B] [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The period from study entry until disease progression, death or date of last contact.

  • --Duration of Response (DR) per cohort [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) per cohort [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS) per cohort [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Overall safety profile [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes of health related quality of life and disease/treatment-related symptoms as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and Lung Cancer module (LC13) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
  • Trough concentrations of PF-00299804 in blood after repeated dosing [ Time Frame: 10months ] [ Designated as safety issue: No ]
  • Best Overall Response (BOR) per RECIST per cohort [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: March 2009
Estimated Study Completion Date: March 2015
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A
Dacomitinib (PF-00299804) in patients with EGFR mutated NSCLC or clinical characteristics defined above to enhance for EGFR mutated NSCLC
Drug: Dacomitinib (PF-00299804)
Dacomitinib (PF-00299804) at 45 mg daily or 30 mg daily by continuous oral dosing, to be escalated in tolerating patients to 45mg after at least 8 weeks of therapy (30 patients in Cohort A started at the lower dose).
Experimental: Cohort B
Dacomitinib in patients with HER2 mutated or amplified NSCLC
Drug: Dacomitinib (PF-00299804)
In Cohort B, patients getting Dacomitinib for first line therapy started at 30 mg, but those who had prior anti-cancer therapy started at 45 mg.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced adenocarcinoma of lung, measurable disease
  • Non-smoker, or former light (less than 10 pack years and stopped at least 15 years); OR
  • patients with known EGFR activating mutation regardless of smoking status
  • ECOG(Eastern Cooperative Oncology Group) 0-1.

Cohort B (select sites only): patients with HER2 amplified or HER2 mutation-positive NSCLC; may have had prior therapy

Exclusion Criteria:

  • Active brain metastases
  • Prior systemic therapy for advanced disease in Cohort A only. Cohort B can have had any number of prior lines of systemic therapy.
  • known EGFR wild type NSCLC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818441

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Antioch, California, United States, 94531
Pfizer Investigational Site
Orange, California, United States, 92868
Pfizer Investigational Site
Pleasant Hill, California, United States, 94523
Pfizer Investigational Site
Salinas, California, United States, 93901
Pfizer Investigational Site
San Francisco, California, United States, 94110
Pfizer Investigational Site
San Francisco, California, United States, 94115
Pfizer Investigational Site
San Leandro, California, United States, 94578
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Florida
Pfizer Investigational Site
Bonita Springs, Florida, United States, 34135
Pfizer Investigational Site
Bradenton, Florida, United States, 34209
Pfizer Investigational Site
Cape Coral, Florida, United States, 33990
Pfizer Investigational Site
Cape Coral, Florida, United States, 33914
Pfizer Investigational Site
Englewood, Florida, United States, 34223
Pfizer Investigational Site
Fort Myers, Florida, United States, 33901
Pfizer Investigational Site
Fort Myers, Florida, United States, 33905
Pfizer Investigational Site
Fort Myers, Florida, United States, 33619
Pfizer Investigational Site
Fort Myers, Florida, United States, 33908
Pfizer Investigational Site
Naples, Florida, United States, 34119
Pfizer Investigational Site
Naples, Florida, United States, 34102
Pfizer Investigational Site
Port Charlotte, Florida, United States, 33980
Pfizer Investigational Site
Sarasota, Florida, United States, 34232
Pfizer Investigational Site
Sarasota, Florida, United States, 34236
Pfizer Investigational Site
Venice, Florida, United States, 34285
Pfizer Investigational Site
Venice, Florida, United States, 34292
United States, Georgia
Pfizer Investigational Site
Ringgold, Georgia, United States, 30736
United States, Maryland
Pfizer Investigational Site
Bethesda, Maryland, United States, 20892-1906
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 022l5
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
United States, Missouri
Pfizer Investigational Site
Branson, Missouri, United States, 65616
Pfizer Investigational Site
Nixa, Missouri, United States, 65714
Pfizer Investigational Site
Springfield, Missouri, United States, 65804
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10065
Pfizer Investigational Site
Stony Brook, New York, United States, 11794-9446
United States, North Carolina
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27514
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27599-7600
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, North Dakota
Pfizer Investigational Site
Bismarck, North Dakota, United States, 58501
United States, Tennessee
Pfizer Investigational Site
Chattanooga, Tennessee, United States, 37404-1130
Pfizer Investigational Site
Chattanooga, Tennessee, United States, 37404
Pfizer Investigational Site
Franklin, Tennessee, United States, 37067
Pfizer Investigational Site
Gallatin, Tennessee, United States, 37066
Pfizer Investigational Site
Hermitage, Tennessee, United States, 37076
Pfizer Investigational Site
Hixson, Tennessee, United States, 37343
Pfizer Investigational Site
Lebanon, Tennessee, United States, 37087
Pfizer Investigational Site
Murfreesboro, Tennessee, United States, 37130
Pfizer Investigational Site
Nashville, Tennessee, United States, 37211
Pfizer Investigational Site
Nashville, Tennessee, United States, 37205
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Pfizer Investigational Site
Nashville, Tennessee, United States, 37207
Pfizer Investigational Site
Smyrna, Tennessee, United States, 37167
United States, Virginia
Pfizer Investigational Site
Mechanicsville, Virginia, United States, 23116
Pfizer Investigational Site
Midlothian, Virginia, United States, 23114
Pfizer Investigational Site
Richmond, Virginia, United States, 23230
Pfizer Investigational Site
Richmond, Virginia, United States, 23235-4730
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98109
Pfizer Investigational Site
Seattle, Washington, United States, 98195
Hong Kong
Pfizer Investigational Site
Tuen Mun, New Territories, Hong Kong, 0
Pfizer Investigational Site
Shatin,, NT, Hong Kong
Japan
Pfizer Investigational Site
Aichi, Japan
Pfizer Investigational Site
Koto-ku, Tokyo, Japan
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00818441     History of Changes
Other Study ID Numbers: A7471017
Study First Received: January 5, 2009
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
lung cancer adenocarcinoma HER2

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014